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Hearing loss is a prevalent and modifiable risk factor for cognitive decline and dementia in older adults, yet access to hearing care remains limited. Over-the-counter (OTC) hearing aids represent a promising and scalable strategy to expand access, particularly for individuals at elevated risk for dementia who may benefit most from earlier intervention. This pilot study aims to evaluate the feasibility and acceptability of OTC hearing aid use among older adults. Participants aged ≥50 years will undergo standardized hearing screening to identify bilateral, mild-to-moderate hearing loss. Eligible participants will be randomized to one of two sequences: (1) immediate intervention: 3-mo using OTC hearing aids or (2) waitlist control: 3-mo without devices followed by OTC hearing aid use after 3 months. Feasibility outcomes include study enrollment and retention, protocol adherence, and average daily device use determined by data-logging. Acceptability outcomes will be assessed using the International Outcome Inventory for Hearing Aids (IOI-HA), device satisfaction ratings, and participant intention to continue hearing-aid use. Hearing outcomes include validated questionnaires on hearing and listening efforts. Findings will inform the design of larger trials aimed at improving access to hearing care and promoting cognitive health.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Intervention | Experimental | Immediate Intervention: 3-month of OTC hearing aid use |
|
| Waitlist control | Active Comparator | Waitlist control: Basic patient education on hearing loss without OTC hearing aid for 3 months, followed by OTC hearing aid fitting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Over-The-Counter (OTC) hearing aid | Device | Over-The-Counter (OTC) hearing aid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility- Proportion of enrolled participants who complete all study periods | Feasibility- Proportion of enrolled participants who complete all study periods | Baseline, 3 months, and 6 months follow-up |
| Feasibility - Enrollment rate (% eligible who consent) | Feasibility - Enrollment rate (% eligible who consent) | Baseline |
| Feasibility - Study visit completion rate (% of planned visits completed) | Feasibility - Study visit completion rate (% of planned visits completed) | Baseline, 3 months, and 6 months follow-up |
| Feasibility - Frequency of device troubleshooting encounters | Feasibility - Frequency of device troubleshooting encounters | Baseline, 3 months, and 6 months follow-up |
| Feasibility - Percentage achieving >= 6hours/day of objective wear time | Feasibility - Percentage achieving >= 4hours/day of objective wear time | Baseline, 3 months, and 6 months follow-up |
| Feasibility - Hearing aid use adherence (mean daily wear time from data-logging) | Feasibility - Hearing aid use adherence (mean daily wear time from data-logging) | Baseline, 3 months, and 6 months follow-up |
| Feasibility - Protocol adherence rate (% completing scheduled assessments) | Feasibility - Protocol adherence rate (% completing scheduled assessments) |
| Measure | Description | Time Frame |
|---|---|---|
| Hearing Handicap Inventory - Screening Version | Hearing Handicap Inventory for the Elderly - Screening Version (HHIE-S) The HHIE-S is a 10-item self-report questionnaire assessing the emotional and social/situational effects of hearing loss in older adults. Total scores range from 0 to 40, with higher scores indicating greater perceived hearing handicap and worse hearing-related quality of life. Minimum score: 0; maximum score: 40. Higher scores represent worse outcomes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Janet Choi, MD | Contact | 323-790-6788 | choilab@usc.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90066 | United States |
At this time, individual participant data (IPD) will not be shared. Because this is a small feasibility pilot study involving a high-risk population, and the primary study outcomes are feasibility and acceptability metrics rather than clinical endpoints, we do not anticipate that sharing individual-level data would provide meaningful scientific value.
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D006310 | Hearing Aids |
| ID | Term |
|---|---|
| D000076251 | Wearable Electronic Devices |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D012682 | Sensory Aids |
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| Baseline, 3 months, and 6 months follow-up |
| Feasibility - Retention rate (% completing follow-up visits) | Feasibility - Retention rate (% completing follow-up visits) | Baseline, 3 months, and 6 months follow-up |
| Acceptability - International Outcome Inventory for Hearing Aids | International Outcome Inventory for Hearing Aids (IOI-HA) The IOI-HA is a 7-item self-report questionnaire assessing hearing aid outcomes across domains including daily use, benefit, residual activity limitation, satisfaction, residual participation restriction, impact on others, and quality of life. Each item is scored on a 5-point Likert scale, with total scores ranging from 7 to 35. Higher scores indicate better hearing aid outcomes and greater perceived benefit/satisfaction. | Baseline, 3 months, and 6 months follow-up |
| Acceptability - Intention to continue use after study completion | Acceptability - Intention to continue use after study completion Participant-reported intention to continue hearing aid use after study completion will be assessed using a Likert-scale questionnaire. Responses are scored on a 5-point scale ranging from 1 to 5, with higher scores indicating greater willingness and acceptability for continued hearing aid use. Minimum score: 1; maximum score: 5. Higher scores represent better outcomes (greater intention to continue use). | Baseline, 3 months, and 6 months follow-up |
| Baseline, 3 months, and 6 months follow-up |
| Vanderbilt fatigue scale | Vanderbilt Fatigue Scale - Adult Hearing Loss (VFS-AHL) The Vanderbilt Fatigue Scale - Adult Hearing Loss (VFS-AHL) is a self-report measure assessing listening-related fatigue in adults with hearing loss. Scores are derived using item-response theory-based scoring and are typically transformed to a standardized scale ranging from approximately -2 to +2 logits, with higher scores indicating greater fatigue and worse outcomes. Higher scores represent worse listening-related fatigue. | Baseline, 3 months, and 6 months follow-up |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |